Maternal and perinatal health research during emerging and ongoing epidemic threats: a landscape analysis and expert consultation

Introduction Pregnant women and their offspring are often at increased direct and indirect risks of adverse outcomes during epidemics and pandemics. A coordinated research response is paramount to ensure that this group is offered at least the same level of disease prevention, diagnosis, and care as the general population. We conducted a landscape analysis and held expert consultations to identify research efforts relevant to pregnant women affected by disease outbreaks, highlight gaps and challenges, and propose solutions to addressing them in a coordinated manner. Methods Literature searches were conducted from 1 January 2015 to 22 March 2022 using Web of Science, Google Scholar and PubMed augmented by key informant interviews. Findings were reviewed and Quid analysis was performed to identify clusters and connectors across research networks followed by two expert consultations. These formed the basis for the development of an operational framework for maternal and perinatal research during epidemics. Results Ninety-four relevant research efforts were identified. Although well suited to generating epidemiological data, the entire infrastructure to support a robust research response remains insufficient, particularly for use of medical products in pregnancy. Limitations in global governance, coordination, funding and data-gathering systems have slowed down research responses. Conclusion Leveraging current research efforts while engaging multinational and regional networks may be the most effective way to scale up maternal and perinatal research preparedness and response. The findings of this landscape analysis and proposed operational framework will pave the way for developing a roadmap to guide coordination efforts, facilitate collaboration and ultimately promote rapid access to countermeasures and clinical care for pregnant women and their offspring in future epidemics.

This is an obstetric surveillance system in Austria Belgian Obstetrics Surveillance System (BOSS) The Belgian Obstetric Surveillance System (B.OSS) was launched in 2011 with the support of the College of Physicians for Mother and Newborn of the Federal Public Service Public Health.B.OSS investigates serious complications that occur during pregnancy or childbirth and that put the life of the mother and/or the unborn child at risk.These are rare complications that affect less than one out of 2,000 women

BetterBirth Program
The BetterBirth Program is a project of the Ariadne Labs focused on ensuring better health and wellbeing for women, newborns, and infants by improving quality and standards of care, minimizing complications, and ending preventable deaths.They do this through the implementation of scalable, evidence-based solutions that work in the real world, both at the frontline of care and in communities.The BetterBirth Program began with the goal of evaluating the World Health Organization's (WHO) Safe Childbirth Checklist and identifying opportunities and strategies to support its successful implementation.Since that time, it has grown to address the complexities across the ecosystem of maternal, newborn, and infant health Brazilian Obstetric Observatory (OOBr) The objective of this project is to create an obstetric observatory through an interactive platform for monitoring, analyzing public data and disseminating information in the area of Obstetrics in Brazil.It will provide exploratory data analysis with the purpose of assessing the GerOSS (German Obstetric Surveillance System) aims at generating deeper insight into relevant risk factors to improve diagnosis and treatment of severe complications during pregnancy and delivery.As such it is primarily conceived as a system for quality improvement and less as a register.Another focus is the provision of an information and communication platform for dissemination of these insights.Finally, incidences of selected rare obstetric events may be derived Global Network Maternal Newborn Health Registry (GN-MNHR) (including COVID study) This is an active maternal and neonatal data collection system with multiple LMIC sites.A prospective, population-based registry that started in 2008; it enrolls and follows up on pregnant women and their newborns up to 42 days postpartum.A sub-study to the Maternal Newborn Health Registry will be conducted to understand the prevalence of COVID-19 among pregnant women, the association between COVID-19 and pregnancy outcomes, and the Knowledge, Attitudes, and Practices of pregnant women related to COVID-19 and its prevention during pregnancy.Women who consent to participation in the MNHR COVID sub-study will provide a blood specimen at or near delivery to be tested for COVID-19 antibodies.Four Global Network sites (Guatemala, Bangladesh, Nagpur India and Pakistan) will also collect and analyze blood specimen from participants during antenatal care visits Global Network Maternal Newborn Health The The goal of the Global Pregnancy Collaboration (CoLab) is to improve the health of mothers and their infants by facilitating harmonized perinatal data management and collaborative research.This is accomplished by developing standardized generic data dictionaries that cover the needs of all maternal child health care-from the simplest in the most resource poor countries to the most sophisticated research in more privileged areas

Global vaccine data network
The GVDN addresses limitations in vaccine safety.They aim to work with vaccine safety and effectiveness experts, global heal th agencies, and other global non profit health alliances to help assure the safety and risk benefit of vaccines through vaccine monitoring b y evaluating vaccine safety concerns through analysis and evaluation of large clinical databases, evaluating vaccine effectiveness to faci lit ate risk/benefit analyses, leading a coordinated response to concerns regarding vaccines, such as vaccine hesitancy, and seeking out a nd securing funding for collaboration on vaccine safety monitoring projects.The organization brings together birth defect surveillance and research programmes from around the world with the aim of investigating and preventing birth defects and lessening the impact of their consequences International Network for Evaluation of Outcomes of Neonates iNeo maintains a standardized neonatal intensive care unit (NICU) database and provides a unique opportunity for researchers to participate in collaborative projects on a national and international scale.Health care professionals, health services researchers and health administrators participate actively in clinical and epidemiological outcomes, health services, health policy and informatics research aimed at improving the efficacy and efficiency of neonatal care International Network of Obstetric Survey Systems The main objective of this study is to investigate the impact of timing of vaccination during pregnancy on humoral immune responses in pregnant women at several timepoints during and after pregnancy Medical Birth Registry of Norway All maternity units in Norway must notify births to the MBRN.The notification form includes the name and personal identity number of the child and parents, as well as information about maternal health before and during pregnancy, and any complications during pregnancy or birth.This includes information about medicine use in pregnancy, labour interventions, birth complications, maternal complications after birth, whether the baby is born alive, any diagnoses in the child or evidence of congenital abnormalities MNCH Morbidity and Mortality Surveillance -HaSET A prospective longitudinal cohort study of pregnant women and children less than two years of age with an aim of understanding the epidemiology of maternal and childhood illnesses and deaths in selected Kebeles of Angolela Tera, Kewet and Shewarobit Woredas in North Shewa Zone, Amhara Region, Ethiopia.Momentum Maternal and Perinatal Death Surveillance and Review (MPDSR) MOMENTUM Country and Global Leadership, the World Health Organization, UNFPA, and UNICEF have developed an integrated Maternal and Perinatal Death Surveillance and Response (MPDSR) Capacity Building Package that can be used to support country capacity for MPDSR through virtual means.Capacity building materials for both maternal and perinatal mortality surveillance have been combined into one package, which also includes updated guidance and COVID-19 modules MotherToBaby MotherToBaby Pregnancy Studies provide information on medication and vaccine safety in pregnancy.Studies are observational; people who are pregnant are not asked to take any medications or change their current treatments.They follow people who are pregnant who haveand who have nottaken a medication of interest until they deliver their baby, and then follow their babies for a period of time after birth.They collect information along the way that allows determination of whether the medication/vaccine may pose a risk to a pregnancy or a developing baby MPD-4-QED (Nigeria) This program was initiated in Nigeria in 2019 across 54 tertiary level public and private referral level health facilities.It was established to implement a standardized electronic platform for the collection and collation of maternal and perinatal data, to enable routine healthcare data analysis and maternal and perinatal death audits.It will facilitate reporting and feedback at the local, state, regional, and national levels for the improvements in clinical care performance.Currently in its third year with >200,000 participants enrolled.

Multi-Omics for Mothers and Infants (MOMI) Biorepository Platform
This platform builds off an existing pregnancy biobank in the Sylhet district of Bangladesh, known as AMANHI-Bangladesh.The AMANHI-Bangladesh biobank contains biological samples from mothers and infants and related clinical and epidemiological data.Researchers use the sample and data collected by the biobank to identify biological and genetic markers that may predict a mother's increased risk of adverse outcomes including preeclampsia, preterm birth, and small for gestational age (smaller or less developed than normal for the baby's sex and gestational age).Through the MOMI Biorepository Platform grant, researchers will maintain the existing biobank infrastructure and develop a BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s) BMJ Glob Health doi: 10.1136/bmjgh-2023-014393 :e014393.9 2024; BMJ Glob Health , et al.Bonet M scale-up plan that will include other biobank sites and partners.Researchers also aim to identify new insights and biomarkers for preterm birth and other pregnancy complications that will help to inform predictors and treatment options.The MOMI Biorepository Platform will also include capacity-building components for research staff and data scientists at the Bangladesh field site National Neonatal Research Database (NNRD) The NNRD is a national resource holding real-world clinical data captured in the course of care on all admissions to NHS neonatal units in England, Wales, Scotland and the Isle of Man.Neonatal units submit data through their Electronic Patient Record system supplier.At present, there is information on around one million babies and 10 million days of care in the NNRD.The mission of the OPRC Network, formerly the Obstetric-Fetal Pharmaceutical Research Units Network, was to improve the safety and effective use of therapeutic drugs in pregnant and lactating people.The network's overall goal was to promote and facilitate cooperative multidisciplinary research to enhance the understanding of obstetric pharmacokinetics (PK) and pharmacodynamics (PD).OPRCs provided the expert infrastructure needed to test therapeutic drugs during pregnancy.The centers allowed researchers to conduct safe, technically sophisticated, and complex studies that helped clinicians protect the health of pregnant people, improve birth outcomes, and reduce infant mortality PAHO Perinatal Information System (SIP) This is an active maternal and neonatal data collection system.Perinatal Informatic System (SIP) by PAHO is a perinatal clinical record that Ministries of health and maternity services (public and private) have adopted peri-COVID The periCOVID study was set up by a group of doctors and researchers who are interested in understanding if pregnant women who test positive for the novel coronavirus (SARS-COV-2) can transmit the infection to their unborn babies and if baby's of mothers who have been vaccinated against SARS-CoV-2 will be protected from The COVI-PREG registry aims to collect data to understand the natural history of the SARS-CoV-2 among pregnant women and the impact on maternal, pregnancy and neonatal outcomes.
Global Network for Women's and Children's Health Research (Global Network) is a partnership dedicated to improving maternal and child health outcomes and building health research capacity in resource-poor settings by testing cost-effective, sustainable interventions that provide guidance for the practice of evidence-based medicine.This unique collaboration includes 8 multidisciplinary research sites and a Data Coordinating Center.Scientific oversight for the Global Network comes from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, which is part of the National Institutes of Health within the U.S. Department of Health and Human Services Global Pregnancy Collaboration (CoLab) (INOSS)    INOSS is a multinational collaboration of organizations conducting prospective population-based studies of serious illnesses in pregnancy and childbirth ISGlobal Maternal, Child, Reproductive Health ResearchThe Barcelona Institute for Global Health (ISGlobal) was set up in 2010 as a result of an initiative of the "la Caixa" Foundation working with academic and government institutions interested in creating a centre of excellence in research and knowledge translation in Barcelona equipped to meet the new challenges facing global health in the 21st century.Our roots, however, go back much further.Today, ISGlobal encompasses over 30 years' experience in the field of health and is a consolidated hub of excellence in scientific research drawing on expertise from both the hospital environment and academic institutions BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s) Network (INN) is a voluntary consortium of all neonatal departments in Israel.The Israel National Very Low Birth Weight VLBW) Infant Database was established in 1995 under the auspices of the INN.The main objectives of the database are the application of quality data for the assessment of morbidity and mortality trends of VLBW infants; benchmarking of individual neonatal unit performance in comparison to national data; quality of care and management; planning of national, regional and institutional structure and policy development; longitudinal developmental assessment and for collaborative research programs Italian Obstetric Surveillance System (ITOSS) The Italian Obstetric Surveillance System (ItOSS) collects and disseminates information on severe maternal morbidity and mortality.Since 2017, the surveillance system of maternal mortality, coordinated by the Istituto Superiore di Sanità (ISS), has been collecting comprehensive and reliable data on maternal mortality in 13 Italian regions (Piedmont, Lombardy, Veneto, Friuli Venezia Giulia, Emilia-Romagna, Marche, Tuscany, Lazio, Campania, Apulia, Calabria, Sicily and Sardinia), accounting for 91% of total births in Italy.Between 2008 and 2016, through the National Centre for Disease Prevention and Control (Centro nazionale per la prevenzione e il controllo delle malattie -CCM), the Ministry of Health consistently funded a series of ISS-coordinated multiregional projects which allowed further development and consolidation of the surveillance JHU International Center for Maternal and Newborn Health This interdisciplinary team applies expertise in public health, behavioral sciences, nutrition, medicine, engineering, and informatics.They rely on workforce development in Sub-Saharan Africa and South Asia to implement and evaluate low-cost solutions to prevent illnesses and deaths in the world's most vulnerable mothers and babies Korean Neonatal Network (KNN) A neonatal surveillance network in Korea Le Comité national d'experts sur la mortalité maternelle (CNEMM) The National Committee of Experts on Maternal Mortality (CNEMM) was created in 1995 by order of the Ministry of Health with the mission of examining maternal deaths documented by a confidential investigation, identifying the factors involved in the occurrence of these deaths and to propose preventive measures.This mission involves a specific information collection system, the National Confidential Survey on Maternal Mortality (ENCMM), whose scientific coordination is ensured by the National Institute of Health and Medical Research (Inserm) (unit 1153 , EPOPé team) Magee Obstetric Maternal and Infant (MOMI) Database and Biobank MOMI Database and Biobank collects obstetric biological materials along with annotated clinical information via a rigorous process for quality control.Our unique, web-based inventory system tracks our biological specimens, linking them to annotated clinical data behind a secure, HIPAA compliant server Malawi Maternal Health and Safe Motherhood Initiative This is a maternity waiting village in malawi, with support from UNC Global Women's health.They have several ongoing studies, several focusing on HIV Maternal health and Covid-19 (MA-CoV) Study Ma-CoV is a study aimed to characterize the clinical presentation of COVID-19 in pregnancy, evaluate the incidence of infection during pregnancy, identify risk factors of maternal and neonatal morbidity and mortality associated with SARS-CoV-2 infection as well as the risk of mother-to-child transmission of SARS-CoV-2 Maternal health task forceThe Maternal Health Task Force (MHTF) at the Harvard Chan School of Public Health strives to create a strong, well-informed and collaborative community of individuals focused on ending preventable maternal mortality and morbidity worldwide.The vision for MHTF is that it serves as a space that not only identifies and shares promising research, but serves as a catalyst for research improvement and innovation BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s) active maternal and neonatal data collection system.INDEPTH is a network of independent Health and Demographic Surveillance System (HDSS) sites that carry out longitudinal research.The INDEPTH Network Maternal, Newborn & Child Health Working Group (MNCH-WG) coordinate the surveillance of pregnancies and outcome tracking Maternal-fetal medicine units (MFMU) network at UPMC Magee-Womens Hospital NICHD established the MFMU Network in 1986 to respond to the need for well-designed clinical trials in maternal-fetal medicine and obstetrics, particularly with respect to preterm birth.The aims of the network are to reduce maternal, fetal, and infant morbidity related to preterm birth, fetal growth abnormalities, and maternal complications and to provide the rationale for evidence-based, cost-effective obstetric practice MATIMMUNE Study The study objectives are to characterize the clinical course of SARS-CoV-2 infection during pregnancy, assess the risk assessment of vertical transmission and congenital lesions, quantify the risk of adverse maternal outcomes, pregnancy outcomes and neonatal outcomes, and identify additional risk factors and risk modifiers Reproductive, Maternal, & Child Health (RMNCH) This is a collaboration of a Nepalese and US-based NGOs, supporting health innovation in Nepal, conducting research and innovation to address evidence, implementation, and policy gaps in the equity, quality and accessibility of healthcare.They have a particular MNCH research division Reproductive, Maternal, Newborn, Child, and Adolescent Health (RMNCAH) division -Impact of COVID-19 on the Health and Nutrition of Women and Children in Lowand Middle-Income Countries study A hub for global child health-focused activities and connects researchers and health-care professionals around the world, with focus on RMNCAH; Special interests in scaling up evidence-based, community setting interventions and implementation of reproductive, maternal, newborn, child and adolescent health and nutrition interventions in humanitarian contexts Safety Platform for Emergency Vaccines (SPEAC) This effort is funded by CEPI to promote harmonization of safety assessment across research platforms and enable meaningful analysis and interpretation of the safety profile of CEPI vaccines Sanofi Pasteur Pregnancy Surveillance Program The Sanofi Pasteur Pregnancy Registries are an organized, systematic collection of data on pregnant women vaccinated with one or more of the following vaccines: Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine), Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed), Fluzone® Quadrivalent (Influenza Virus Vaccine), MenQuadfi® (Meningococcal [groups A, C, Y, W] conjugate vaccine), Dengvaxia®(Dengue tetravalent vaccine, live, attenuated), Flublok® Quadrivalent (Influenza Virus Vaccine)BMJ Publishing Group Limited (BMJ) disclaims all liability and responsibility arising from any reliance Supplemental material placed on this supplemental material which has been supplied by the author(s)

Supplementary Material 2. Data extraction form
[Free text covering e.g., detailed instructions on methodology, outcomes measured, reporting processes, cadence, identification and how to amend protocols etc.] [Y/N against outcomes measured, including spontaneous abortion/miscarriage (10-19 wks gestation), stillbirth, preterm birth (<28wks, <32wks), low birth weight, NICU admission, maternal death, neonatal mortality (28 day)] Other data priorities [Free text] Data collection [Free text covering type of platforms, license & database, policies around data privacy & protection and definition of outcomes, + Y/N against ability to share and integrate data] Funding & governance [Free text covering sponsor / funding, institutions in charge of dev./ updates, cost for emergency research] Emergency response [Free text covering any emergency response work currently conducted, and potential to pivot to emergency response in future] Opportunities [Free text covering any advantages of the site / network e.g.speed, practical use of data etc.] Challenges [Free text covering challenges e.g.funding for emergency response, comparison group, deidentified info etc.] Supplementary material 3.

Research efforts identified in desk review Effort (s) Brief descriptions
AlignMNHAlignMNH is a global initiative funded by the Bill & Melinda Gates Foundation in collaboration with the United States Agency for International Development.The initiative was founded in 2020 to accelerate progress in improving maternal and newborn health outcomes and prevent stillbirths around the globe.AlignMNH is supported by a Secretariat, managed by Jhpiego, an international NGO focused on transformative health care solutions that save lives.AlignMNH works in partnership with global and country-based organizations, national-level technical working groups, and other MNH-focused initiatives to more rapidly share science, evidence and programmatic experience across the maternal and newborn health communities Alliance for Maternal and Newborn Health Improvement (AMANHI) StudyThe Alliance for Maternal and Newborn Health Improvement (AMANHI) study in Sylhet district, Bangladesh, is using ongoing newborn intervention trials to obtain data critical to maternal, fetal and newborn health The Australasian Maternity Outcomes Surveillance System (AMOSS) is a national surveillance mechanism designed to study a variety of rare or serious conditions in pregnancy, childbirth and the postnatal phase in Australia and New Zealand.Through translating the findings from these studies into reliable evidence-based practice, the aim of AMOSS is to improve the safety and quality of maternity care in Australia and New Zealand Australia and New Zealand Neonatal Network The Australian and New Zealand Neonatal Network (ANZNN) is a collaborative network that monitors the care of high risk newborn infants by pooling data to provide quality assurance for this resource consuming care.The network was established in 1994 under the recommendation of the National Health and Research Council's (NHMRC) Expert Panel on Perinatal Morbidity.Since its establishment the network has developed a minimum data set and implemented a data collection that monitors the mortality and morbidity of infants admitted to neonatal intensive care units across Australia and New Zealand Austrian obstetric surveillance system (AuOSS) Grupo Castrillo-Spanish Neonatal Network Grupo Castrillo is a Spanish network for neonatal infections surveillance.Since 1995 the network is collecting prospective data about neonatal sepsis and antimicrobial resistance, viral infections, congenital infections, and other related topics (infectious biomarkers, central catheter complications, etc.) Helping Mothers Survive and Helping Babies Survive Jhpiego participates in a consortium of global partners to provide and promote these training programs that provide evidence-based learning modules designed to improve and sustain the skills of midwives, nurses, doctors, and those who provide direct care during pregnancy, labor and birth.India/Maathri Maternal and perinatal Health Research collaboration, India ( MaatHRI ) is a UK India collaboration for maternal and perinatal health research established in September 2018.MaatHRI means 'mother' in Sanskrit.Currently, MaatHRI includes sixteen hospitals across six states in India.It is a partner to the INOSS network.Interagency working group on reproductive health in crises IAWG is an international coalition of organizations and individuals working collectively to advance sexual and reproductive health and rights in humanitarian settings INTERCOVID studyThis is the next phase of the INTERGROWTH 21ST project.It is a study aimed to develop new "prescriptive" standards describing normal fetal growth, preterm growth and newborn nutritional status in eight geographically diverse populations, and to relate these The NNRD is available to support audit, evaluations, bench-marking, quality improvement and clinical, epidemiological, health services and policy research to improve patient care and outcomes National Registry for surveillance and epidemiology of perinatal Covid-19 infections This National Registry represents a collaboration between the American Academy of Pediatrics Section on Neonatal-Perinatal Medicine, the Vermont-Oxford Network (VON) and MedNAX (an organization of private neonatologist)hNEOCOSUR networkThis network includes 36 public and private tertiary centers, all University-affiliated.They aim to conduct continuous evaluation of mortality and morbidity of very low birth weight infants (VLBWI) population in the region, develop of predictive adjustment tools that allow benchmarking between centers, conduct clinical observational studies with data provided from the DBU, and non-interventional prospective studies, and design/ conduct clinical trials to evaluate the effectiveness of specific therapeutic interventions Neonatal Research Network Japan This is the Neonatal research network database in Japan.All infants who were born in the participating hospitals with gestational age less than 32 weeks and with birth weight at or less than 1500g admitted to participating facilities within 28 days after birth are registered in the database.Those infants who were born alive but died in a delivery room are also included.As of January 1, 2021, 131 perinatal centers are participating in the network NethOSS This is an obstetric surveillance system collecting data from Netherlands.It is a partner of INOSS Nordic Obstetrics Surveillance System (NOSS) This is an obstetric surveillance system collecting data from the Nordic countries COVID-19 infectionPerinatal Problem Identification Programme The Perinatal Problem Identification Program (PPIP) is a tool that makes perinatal and maternal death audits easier.It provides simple analysis on monthly deaths, causes of death and avoidable factors Pregnancy and Neonatal Outcomes in COVID-19 (PAN-COVID) PAN-COVID is a global registry of women with suspected COVID-19 or confirmed SARS-CoV-2 infection in pregnancy and their neonates; understanding natural history to guide treatment and prevention.The overall aims of PAN-COVID are to evaluate the association of suspected COVID-19 and confirmed SARS-CoV-2 infection in women in pregnancy with: 1. Miscarriage, 2. Fetal growth restriction and stillbirth, 3. Pre-term delivery, 4. Vertical transmission.They collaborate with 13 other national and international COVID-related maternal PRAMS, the Pregnancy Risk Assessment Monitoring System, is a surveillance project of the Centers for Disease Control and Prevention (CDC) and health departments.Developed in 1987, PRAMS collects jurisdiction-specific, population-based data on maternal attitudes and experiences before, during, and shortly after pregnancy.PRAMS surveillance currently covers about 81% of all U.S. births PRiSMA PRiSMA is a network of sites funded by BMGF collecting anthropometric, sociodemographic, pregnancy, and child health data.They conduct epidemiological studies, but are also developing the capacity to conduct clinical trials in their populationsQoC WHOThe goal of the Quality of Care is to work with the WHO to develop national quality and operational plan to reduce maternal and neonatal mortality.QoC programmes have been set up in Bangladesh, Cote d'Ivoire, Ethiopia, Ghana, India, Kenya, Malawi, Sierrra Leone, Tanzania, Uganda Registry for pregnant women exposed to SARS-CoV-2 (COVID-19, CONSIGN study)